Comparing the Quality of Analgesia With Pectoral Nerve Block and Serratus Plane Block in Modified Radical Mastectomy

NCT05224310 | Completed

• 1 other identifier: PECS vs SAP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The use of pectoral nerve block (PECSB) is a new technique during modified radical mastectomy MRM. The Serratus anterior Plane (SAP) Block has been proven to be an effective component of multimodal analgesia regimens for a variety of thoracic procedures including MRM. In this study, the investigators will assess and compare the quality of analgesia with ultrasound-guided Serratus plane block and pectoral nerve block in patients undergoing modified radical mastectomy MRM.

Conditions

Mastectomy; Breast Cancer

Keywords

analgesia; postoperative pain; PECS block; SAP block

Outcome Measures

Primary Outcomes (1)

• The first request for analgesia

  the time from the completion of the block to the time of the first request for analgesia.

  immediately at the end of 24 hours post operatively

Secondary Outcomes (1)

• Post-operative pain

  immediately postoperatively 0,2,4,6,8,12,14,16,18,20,22,and 24 h after surgery at rest

Study Arms (2)

Pectoral nerve block

ACTIVE COMPARATOR

Starting from the lateral third of the clavicle and moving distally and laterally to the midaxillary line. The pectoral major and minor muscles will be identified and 10 mL of bupivacaine 0.25% will be injected between the 2 muscles, and then move the ultrasound probe towards the axilla until the serratus anterior is identified above the second, third, and fourth ribs then injection of 20 mL of bupivacaine 0.25% after negative aspiration into the fascial plane between pectoralis minor and serratus anterior muscles.

Procedure: PECS block, SAP block

Serratus anterior plane block

ACTIVE COMPARATOR

Aiming to find the serratus anterior muscle the investigator will identify the fifth rib in the midaxillary line by the linear probe in the sagittal plane. The latissimus dorsi muscle (superficial and posterior), teres major muscle (superior) and serratus muscles (deep and inferior) will be detected using ultrasound. The investigator will penetrate the serratus anterior muscle by a 23 GA, 35 mm needle in-plane to ultrasound probe from supero-anterior to postero-inferior to inject deep to it.

Procedure: PECS block, SAP block

Interventions

PECS block, SAP block PROCEDURE

performing either PECS block or SAP block

Pectoral nerve block; Serratus anterior plane block

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female patients with breast cancer undergoing modified radical mastectomy surgery under general anaesthesia
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult, female patients,
• ASA physical status I, II, and III
• Aged older than 18 years
• Scheduled for modified radical mastectomy surgery under general anaesthesia.

You may not qualify if:

• Any known allergies to the study drugs.
• Apparent anatomical abnormalities or infections in the serratus region.
• Bleeding disorders e.g. thrombocytopenia, high INR, high PT in the chronic liver or impaired kidney).
• Patients on chronic pain medications or regularly receiving analgesics.
• Pregnant or breastfeeding patients.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, 2685, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms; Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Abdelrhman Alshawadfy, MD

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and intensive care

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 4, 2022
• Study Start: April 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

EG (1)